FDA Adverse Event Malfunction Summary report: N

ENDOTAK RELIANCE

MDR report key: 3904544 · Received July 1, 2014

Report

Report Number: 2124215-2014-11112
Event Type: Malfunction
Date Received: July 1, 2014
Date of Event: April 14, 2014
Report Date: April 14, 2014
Manufacturer: CPI - DEL CARIBE
Product Code: NVY
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EMITTED BEEPING TONES. UPON INTERROGATION IN CLINIC IT WAS DISCOVERED THAT THE DEVICE HAD RECORDED A HIGH OUT OF RANGE RIGHT VENTRICULAR (RV) SHOCK LEAD IMPEDANCE GREATER THAN 200 OHMS. DURING INTERROGATION, ALL RV PARAMETERS WERE WITHIN NORMAL LIMITS, INCLUDING SHOCK IMPEDANCE. IT WAS ALSO FOUND THAT THE PATIENT'S RIGHT ATRIAL (RA) AND LEFT VENTRICULAR (LV) LEADS EXHIBITED HIGH PACING THRESHOLDS AND LOSS OF CAPTURE (LOC). NO FURTHER TESTING WAS PERFORMED AT THAT TIME. ADDITIONAL INFORMATION WAS LATER RECEIVED THAT A REVISION PROCEDURE TOOK PLACE WHEREIN THE LV LEAD WAS EXTRACTED AND IT WAS FOUND THAT THE LEAD WAS FRACTURED AT THE POINT OF THE SUTURE SLEEVE. IN ATTEMPTING TO EXPLANT THE RA LEAD THE PHYSICIAN UNINTENTIONALLY CUT THE LEAD. THE RV LEAD WAS TESTED VIA A PACING SYSTEM ANALYZER (PSA) WITH NORMAL MEASUREMENTS, HOWEVER SHOCK IMPEDANCES COULD NOT BE VERIFIED BY THIS MEANS. THE RA AND LV LEADS WERE REPLACED AND THE CRT-D AND RV LEAD REMAIN IN SERVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
383010	ENDOTAK RELIANCE		NVY	CPI - DEL CARIBE	0295

Patients

Seq	Age	Sex	Outcome	Treatment
1				4543\| 4480\| 0295\| P162